French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )

HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. However, the rate of HBe seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and emtricitabine. This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion.

proportion of patients with no more HBs antigen. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]

proportion of patients with HBV DNA below 2.3 log 10 copies per ml in relation with 3TC resistance or not before tenofovir treatment; increased of ALT before tenofovir treatment;duration of tenofovir treatment before study. [ Time Frame: before tenofovir treatment, duration of tenofovir treatment before study ] [ Designated as safety issue: No ]

Biological evolution and histological of hepatic activity and fibrosis. [ Time Frame: at day 0 and Week 72 ] [ Designated as safety issue: No ]

Many HBV-HIV co-infected patients are currently treated with dual activity drugs such as tenofovir and emtricitabine, often in combination. However, despite the potent antiviral activity of these drugs, the rate of HBe seroconversion is quite low, and not always sustained over time. HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. On the other hand, treatments with antiviral and immuno-modulator activity such as Peg-interferon, are infrequently used in co-infected patients, despite promising data in the field of HBV mono-infection with increased rates and sustained HBe seroconversions. This pilot study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment (180 micro-g once a week, by injection), in 55 patients already treated by tenofovir and emtricitabine for at least 6 months, and who did not reached HBe seroconversion

Previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months

Exclusion Criteria:

HIV 2 infection

Hepatitis C or D

Opportunistic infection

Alcool consummation more than 50g/d

Cirrhosis

Pregnancy or plan of pregnancy

Breastfeeding

Immunosuppressive or modulating of the immune response treatment

Other Hepatitis B treatments than tenofovir, lamivudine or emtricitabine since 6 months

Malabsorption

Exclusive HIV therapy with Truvada

Evolutive cancer under chemotherapy

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00391638